SONOLINE Antares Diagnostic Ultrasound System.
FDA Recall Z-0041-04 · Posted 2003-10-15
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Date Initiated2003-09-05
Date Terminated2004-01-29
Product Quantity136 units
Reason for Recall
Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
Firm Action
On 9/5/03 the firm issued a letter dated September 2003 via overnight delivery. The letter states that a CD-Rom is included that provides a new manual that is to replace the previous manual. The new manual provides information that was previously omitted regarding the ALARA information.
Root Cause
Other
Distribution Pattern
The firm distributed units to 37 hospitals and medical centers nationwide. International distribution includes No military or government distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement